Suture-securing device

ABSTRACT

A suture-securing device includes a first tubular element, shaped to define a first lumen therethrough, and having first and second ends; and a second tubular element, shaped to define a second lumen therethrough, and having first and second ends. The suture-securing device is configured to have (a) an unlocked configuration in which the first end of the second tubular element is disposed closer to the first end of first tubular element than is the second end of the second tubular element, and the sutures are disposable within and slidable through the first and second lumens, and (b) a locking configuration in which the second end of the second tubular element is disposed closer to the first end of first tubular element than is the first end of the second tubular element, and the sutures are inhibited from sliding through the first and second lumens. Other embodiments are also described.

FIELD OF THE INVENTION

Some applications of the present invention relate in general to surgicaltechniques. More specifically, some applications of the presentinvention relate to techniques for securing sutures. More specifically,some applications of the present invention relate to transluminaltechniques for securing sutures.

BACKGROUND

Functional tricuspid regurgitation (FTR) is governed by severalpathophysiologic abnormalities such as tricuspid valve annulardilatation, annular shape, pulmonary hypertension, left or rightventricle dysfunction, right ventricle geometry, and leaflet tethering.Treatment options for FTR are primarily surgical. The current prevalenceof moderate-to-severe tricuspid regurgitation is estimated to be 1.6million in She United States. Of these, only 8,000 patients undergotricuspid valve surgeries annually, most of them in conjunction withleft heart valve surgeries.

SUMMARY OF THE INVENTION

In some applications of the invention, apparatus and methods areprovided for fixedly coupling sutures to each other. For some suchapplications, the apparatus comprises a suture-securing device thatcomprises two tubular elements that are movably coupled to each other.For other such applications, the apparatus comprises a suture-securingdevice that comprises a casing and a core that are movably coupled toeach other. Both suture-securing devices described have an unlockedconfiguration, in which sutures are generally slidable through thedevice, and a locking configuration, in which the sutures are generallynot slidable through the device.

In some applications of the invention, the suture-securing devices areconfigured to be biased to moving toward the locking configurationthereof, and are retained in the unlocked configuration by a constraint.For such applications, the devices automatically move toward the lockingconfiguration when the constraint is removed.

In some applications of the invention, techniques are provided for usingthe suture-securing device to repair a heart valve, by fixedly couplingtogether sutures that are coupled to different parts of the annulus ofthe valve.

In some applications of the invention, apparatus and methods areprovided for repairing a heart valve by sandwiching valve leafletsbetween a support and a securing element, such that multiple orificesare formed between respective portions of the valve leaflets. Typically,the support is generally disc-shaped, and comprises a wire-mesh.Typically, the securing element comprises a plurality of arms, one endof each arm coupled to a central core, and the other end of each armcoupled to leaflet-piercing elements, which protrude through the valveleaflets and into the wire mesh of the support.

There is therefore provided, in accordance with an application of thepresent invention, apparatus for use with a heart valve of a patient,the heart valve including at least two leaflets, the apparatusincluding:

a support, having a leaflet-engaging side, configured to be placedagainst a first side of the heart valve in a position in whichrespective portions of the leaflet-engaging side of the support aredisposed against respective regions of respective leaflets of the valve;and

a plurality of leaflet-piercing elements, deliverable to a second sideof the heart valve of the patient, and configured to couple the supportto the heart valve by (1) piercing the leaflets of the heart valve fromthe second side of the heart valve to the first side of the heart valve,and (2) coupling to the support while the support is in the position onthe first side of the heart valve.

In an application, the support is flat.

In an application, the support is disc-shaped.

In an application, the support has a delivery configuration in which thesupport is generally cylindrical, and a deployed configuration in whichthe support is generally flat.

In an application, the support includes a braided wire mesh.

In an application, the leaflet-piercing elements include straightspikes.

In an application, the leaflet-piercing elements include barbs.

In an application, the leaflet-piercing elements include hooks.

In an application, the leaflet-piercing elements are configured tocouple to the support by being configured to protrude into the support.

In an application, the leaflet-piercing elements are configured tocouple to the support by being configured to protrude through thesupport.

In an application, the support is transluminally deliverable to thefirst side of the heart valve of the patient.

In an application, the leaflet-piercing elements are transluminallydeliverable to the second side of the heart valve independently of thesupport.

In an application, the apparatus further includes a securing element,including:

a core;

two or more arms, an inner end of each arm being coupled to the core,and the arms extending radially outward from the core; and

the leaflet-piercing elements, coupled to respective outer ends of eacharm.

In an application, the securing element is transluminally deliverable tothe second side of the heart valve independently of the support.

In an application, the apparatus is configured such that theleaflet-engaging elements are configured to be coupled to the support bythe securing element being configured to be coupled to the support.

In an application, the apparatus is configured such that coupling theleaflet-engaging elements to the support while the support is in theposition on the first side of the heart valve, sandwiches the leafletsof the heart valve between the support and the securing element.

In an application, the core defines a coupling portion, configured tocouple the core to the support.

In an application, the apparatus is configured such that the coupling ofthe core to the support facilitates the coupling of the leaflet-piercingelements to the support.

In an application, the support defines an inner perimeter that definesan opening through the support, and the coupling portion is configuredto couple the core to the support, by being configured to secure atleast part of the coupling portion within the opening.

In an application, the core is configured to extend between the leafletsof the heart valve, from the second side of the heart valve to the firstside of the heart valve, such that the coupling portion is couplable tothe support at the first side of the heart valve.

In an application, the securing element has a delivery configuration anda deployed configuration, and the outer end of the arms are closer toeach other in the delivery configuration than in the deployedconfiguration.

In an application:

the securing element is disposable within a sheath, and is removablefrom the sheath,

the delivery configuration defines a constrained configuration, thesheath being configured to constrain the securing element in theconstrained delivery configuration,

the deployed configuration defines an unconstrained configuration, and

the securing element is configured to automatically move from thedelivery configuration to the deployed configuration when the securingelement is removed from the sheath.

There is further provided, in accordance with an application of thepresent invention, a method for use with a heart valve of a patient, theheart valve including at least two leaflets, the method including:

delivering, to a first side of the heart valve, a support, having aleaflet-engaging side;

delivering, to a second side of the heart valve, a plurality ofleaflet-piercing elements;

piercing the leaflets of the valve, from the second side to the firstside of the valve, with the leaflet-piercing elements; and

coupling the support to the leaflets, such that respective portions ofthe leaflet-engaging side of the support are disposed against respectiveregions of respective leaflets, by coupling, at the first side of thevalve, the leaflet-piercing elements to the support.

In an application, delivering the support includes delivering a flatsupport.

In an application, delivering the support includes delivering adisc-shaped support.

In an application, delivering the support includes delivering a supportthat includes a braided wire mesh.

In an application, delivering the support includes:

percutaneously delivering the support while the support is in agenerally-cylindrical delivery configuration thereof, and

subsequently, deploying the support into a generally flat deployedconfiguration thereof.

In an application, coupling the leaflet-piercing elements to the supportincludes advancing the leaflet-piercing elements into the support.

In an application, coupling the leaflet-piercing elements to the supportincludes advancing the leaflet-piercing elements through the support.

In an application, delivering the leaflet-piercing elements includesdelivering the leaflet-piercing elements independently of delivering thesupport.

In an application, delivering the leaflet-piercing elements includesdelivering, to the second side of the valve, a securing element thatincludes (1) a core, (2) two or more arms, an inner end of each armbeing coupled to the core, and the arms extending radially outward fromthe core, and (3) the leaflet-piercing elements, coupled to respectiveouter ends of each arm.

In an application, coupling the leaflet-piercing elements to the supportincludes coupling the securing element to the support.

In an application, coupling the securing element to the support includessandwiching the leaflets between the securing element and the support.

In an application, coupling the securing element to the support includescoupling the core to the support, and coupling the core to the supportfacilitates coupling the leaflet-piercing elements to the support.

In an application, the core defines a coupling portion, and coupling thesecuring element to the support includes coupling the coupling portionof the core to the support.

In an application, coupling the coupling portion to the supportfacilitates the coupling of the leaflet-piercing elements to thesupport.

In an application, the support defines an inner perimeter that definesan opening through the support, and coupling the coupling portion of thecore to the support includes securing at least part of the couplingportion within the opening.

In an application, coupling the coupling portion of the core to thesupport, includes coupling the coupling portion to the support at thefirst side of the heart valve.

In an application, coupling the coupling portion to the support includesmoving at least part of the coupling portion, from the second side ofthe heart valve, between the leaflets of the heart valve, to the firstside of the heart valve.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with one or more sutures, theapparatus including:

a first tubular element, shaped to define a first lumen therethrough,and having a first end and a second end; and

a second tubular element, shaped to define a second lumen therethrough,and having a first end and a second end,

the apparatus having:

-   -   an unlocked configuration in which:        -   the first end of the second tubular element is disposed            closer to the first end of the first tubular element than is            the second end of the second tubular element, and        -   the sutures are disposable within and slidable through the            first and second lumens, and a locking configuration in            which:        -   the second end of the second tubular element is disposed            closer to the first end of the first tubular element than is            the first end of the second tubular element, and        -   the sutures are inhibited from sliding through the first and            second lumens.

In an application, the second tubular element has a length, from thefirst end of the second tubular element to the second end of the secondtubular element, that is smaller than the cross-sectional diameter ofthe first lumen.

In an application, the sutures include a first suture and a secondsuture, and the apparatus having a locking configuration in which thesutures are inhibited from sliding through the first and second lumens,includes the apparatus having a locking configuration in which the firstsuture is inhibited from moving with respect to the second suture.

In an application, the apparatus is configured such that:

in the unlocked configuration, the second end of the second tubularelement is disposed outside of the first lumen, and

in the locking configuration, the second end of the second tubularelement is disposed within the first lumen.

In an application, the second end of the first tubular element iscoupled to the first end of the second tubular element.

In an application, the apparatus is configured such that, when thesutures are disposed within the lumens of the first and second tubularelements, movement of the apparatus from the unlocked to the lockingconfiguration rotates at least a portion of each suture.

In an application, the apparatus is configured such that movement of theapparatus from the unlocked to the locking configuration rotates thesecond tubular element.

In an application, the first and second tubular elements include acontinuous piece of material.

In an application, the first tubular element is shaped such that thefirst lumen has a cross-sectional diameter that is greater than across-sectional diameter of the second lumen.

In an application, the first tubular element is shaped such that thefirst lumen has a cross-sectional diameter that is more than 1.1 timesgreater than the cross-sectional diameter of the second lumen.

In an application, the first tubular element is shaped such that thefirst lumen has a cross-sectional diameter that is less than 1.5 timesgreater than the cross-sectional diameter of the second lumen.

In an application:

the unlocked configuration includes a constrained configuration, and thelocking configuration includes an unconstrained configuration, and

the apparatus is configured to be retained in the constrained unlockedconfiguration by a constraining force, and to automatically move towardthe unconstrained locking configuration when the constraining force isremoved.

In an application, the apparatus further includes a constraint,configured to provide the constraining force.

In an application, the constraint includes a rod, disposable in thelumen of at least one of the tubular elements, configured to provide theconstraining force by being disposed in the lumen, the constrainingforce being removable by removing the rod from the lumen.

In an application, the constraint includes a constraining sheath,configured to provide the constraining force by being disposed around atleast one of the tubular members, the constraining force being removableby removing the sheath from the at least one of the tubular members.

In an application, the first and second tubular elements both definerespective inner and outer surfaces, and, in the locking configuration,at least part of the outer surface of the second tubular element isdisposed against at least part of the inner surface of the first tubularelement.

In an application, the apparatus is configured such that, when thesutures are disposed within the lumens of the first and second tubularelements, movement of the apparatus from the unlocked to the lockingconfiguration sandwiches at least a portion of each suture between theouter surface of the second tubular element and the inner surface of thefirst tubular element.

In an application, the apparatus includes at least one helical element.

In an application, at least in the unlocked configuration, the apparatusdefines a continuous helix from the first end of the first tubularelement to the second end of the second tubular element.

In an application, the first tubular element includes a first helicalelement and the second tubular element includes a second helicalelement.

In an application, the second end of the first tubular element iscoupled to the first end of the second tubular element by a connectingportion.

In an application, the tubular elements and the connecting portioninclude a continuous piece of material.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with one or more sutures, theapparatus including:

a first tubular element, shaped to define a first lumen therethrough,and having a proximal end and a distal end; and

a second tubular element, shaped to define a second lumen therethrough,and having a first end and a second end,

the apparatus having:

-   -   an unlocked configuration in which:        -   the second end of the second tubular element is disposed            distally to the first end of the second tubular element, and        -   the sutures are disposable within and slidable through the            first and second lumens, and    -   a locking configuration in which:        -   the first end of the second tubular element is disposed            distally to the second end of the second tubular element,            and        -   the sutures are inhibited from sliding through the first and            second lumens.

In an application, the apparatus is configured such that:

in the unlocked configuration, the second end of the second tubularelement is disposed outside of the first lumen, and

in the locking configuration, the second end of the second tubularelement is disposed within the first lumen.

In an application, the apparatus is configured such that, when thesutures are disposed within the lumens of the first and second tubularelements, movement of the apparatus from the unlocked to the lockingconfiguration rotates at least a portion of each suture.

In an application, the first and second tubular elements both definerespective inner and outer surfaces, and, in the locking configuration,at least part of the outer surface of the second tubular element isdisposed against at least part of the inner surface of the first tubularelement.

In an application, the apparatus is configured such that, when thesutures are disposed within the lumens of the first and second tubularelements, movement of the apparatus from the unlocked to the lockingconfiguration sandwiches at least a portion of each suture between theouter surface of the second tubular element and the inner surface of thefirst tubular element.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with one or more sutures, theapparatus including:

a first tubular element, shaped to define a first lumen therethrough;and

a second tubular element, coupled to the first tubular element, andshaped to define a second lumen therethrough,

the apparatus having:

-   -   an unlocked configuration in which at least a quarter of the        second tubular element is disposed outside of the first lumen,        and the sutures are disposable within and slidable through the        first and second lumens, and    -   a locking configuration in which at least a quarter of the        second tubular element is disposed inside the first lumen, and        the sutures are inhibited from sliding through the first and        second lumens, and

the apparatus being constrainable in the unlocked configuration by aremovable constraining force, and configured to automatically movetoward the second configuration when the constraining force is removed.

In an application, the apparatus is configured such that, when thesutures are disposed within the lumens of the first and second tubularelements, movement of the apparatus from the unlocked to the lockingconfiguration rotates at least a portion of each suture.

In an application, the first and second tubular elements both definerespective inner and outer surfaces, and, in the locking configuration,at least part of the outer surface of the second tubular element isdisposed against at least part of the inner surface of the first tubularelement.

In an application, the apparatus is configured such that, when thesutures are disposed within the lumens of the first and second tubularelements, movement of the apparatus from the unlocked to the lockingconfiguration sandwiches at least a portion of each suture between theouter surface of the second tubular element and the inner surface of thefirst tubular element.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with one or more sutures, theapparatus including:

a first tubular element, shaped to define a first lumen therethrough;and

a second tubular element shaped to define a second lumen therethrough,the second tubular element being coupled to the first tubular element ata coupling point, the coupling point being configured to facilitatedeflection of the second tubular element around the coupling point, and

the apparatus:

-   -   having an unlocked configuration in which the sutures are        disposable within and slidable though the first and second        lumens, and a locking configuration in which the sutures are        inhibited from sliding through the first and second lumens,    -   being configured to be constrainable in the unlocked        configuration by a constraining force, and    -   being configured, when the constraining force is removed, to        automatically move from the unlocked configuration to the        locking configuration, by the second tubular element deflecting        around the coupling point.

In an application, the apparatus is configured such that, when thesutures are disposed within the lumens of the first and second tubularelements, the deflecting of the second tubular element around thecoupling point rotates at least a portion of each suture.

In an application, the first and second tubular elements both definerespective inner and outer surfaces, and, in the locking configuration,at least part of the outer surface of the second tubular element isdisposed against at least part of the inner surface of the first tubularelement.

In an application, the apparatus is configured such that, when thesutures are disposed within the lumens of the first and second tubularelements, the deflecting of the second tubular element around thecoupling point sandwiches at least a portion of each suture between theouter surface of the second tubular element and the inner surface of thefirst tubular element.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with one or more sutures, theapparatus including:

a casing, shaped to define a cavity, and one or more openings in whichthe sutures are disposable;

a core, disposed in the cavity, and shaped to define a lumen in whichthe sutures are disposable,

the apparatus:

-   -   having an unlocked configuration in which the sutures are        disposable within and slidable through the openings and the        lumen, and a locking configuration in which the sutures are        inhibited from sliding through the openings and the lumen,    -   being movable from the unlocked configuration to the locking        configuration, and    -   being configured such that, when the sutures are disposed within        the openings and the lumen, and the apparatus moves from the        unlocked configuration to the locking configuration, the        apparatus (1) cuts the sutures at a cutting site of the        apparatus, and (2) becomes coupled to the sutures at a coupling        site of the apparatus.

In an application:

the casing defines two or more openings, the openings being providedalong a longitudinal axis of the casing, in the unlocked configurationof the apparatus, the lumen of the core is disposed along the axis, andbetween the openings, and

in the locking configuration of the apparatus, the core is disposed withrespect to the casing in a manner in which the lumen of the core is notdisposed along the axis.

In an application:

the casing defines two or more openings,

in the unlocked configuration of the apparatus, the lumen of the core isgenerally in fluid communication with the openings, and

in the locking configuration of the apparatus, the lumen of the core isgenerally not in fluid communication with the openings.

In an application:

the unlocked configuration includes a constrained configuration, and thelocking configuration includes an unconstrained configuration, and

the apparatus is configured to be retained in the constrained unlockedconfiguration by a constraining force, and to automatically move towardthe unconstrained locking configuration when the constraining force isremoved.

In an application, the apparatus further includes a constraint,configured to provide the constraining force.

In an application, the constraint includes a constraining sheath.

In an application, the cutting site includes at least one cutting edge,and the apparatus is configured to cut the sutures by pushing thesutures against the cutting edge.

In an application:

the at least one cutting edge includes first and second cutting edges,

the casing is shaped to define the first cutting edge, and

the core is shaped to define the second cutting edge.83. A method foruse with one or more sutures at an anatomical site of a patient, themethod including:

delivering, to a vicinity of the anatomical site, apparatus thatincludes (1) a first tubular element, shaped to define a first lumentherethrough, and having a first end and a second end, and (2) a secondtubular element, shaped to define a second lumen therethrough, andhaving a first end and a second end;

sliding the apparatus over at least part of the sutures while theapparatus is in an unlocked configuration thereof in which (1) the firstend of the second tubular element is disposed closer to the first end ofthe first tubular element than is the second end of the second tubularelement, and (2) the sutures are slidable through the first and secondlumens; and

securing the apparatus to the sutures by moving the apparatus into alocking configuration thereof in which: (1) the second end of the secondtubular element is disposed closer to the first end of the first tubularelement than is the first end of the second tubular element, and (2) thesutures are inhibited from sliding through the first and second lumens.

There is further provided, in accordance with an application of thepresent invention, a method for use with one or more sutures at ananatomical site of a patient, the method including:

delivering, to a vicinity of the anatomical site, apparatus thatincludes (1) a first tubular element, shaped to define a first lumentherethrough, and having a first end and a second end, and (2) a secondtubular element, shaped to define a second lumen therethrough, andhaving a first end and a second end;

sliding the apparatus over at least part of the sutures while theapparatus is in an unlocked configuration thereof in which (1) the firstend of the second tubular element is disposed closer to the first end ofthe first tubular element than is the second end of the second tubularelement, and (2) the sutures are slidable through the first and secondlumens; and

subsequently inhibiting the sutures from sliding through the first andsecond lumens by moving the apparatus into a locking configuration inwhich the second end of the second tubular element is disposed closer tothe first end of the first tubular element than is the first end of thesecond tubular element.

In an application, in the unlocked configuration, the second end of thesecond tubular element of the apparatus is disposed outside of the firstlumen, and moving the apparatus into the locking configuration includesmoving the second end of the second tubular element into the firstlumen.

In an application, moving the apparatus into the locking configurationincludes moving at least a quarter of the second tubular element intothe first lumen.

In an application, moving the apparatus into the locking configurationincludes sandwiching at least a portion of each suture between an outersurface of the second tubular element and an inner surface of the firsttubular element.

In an application, the apparatus is configured to be constrained in theunlocked configuration by a constraining force, and moving the apparatusinto the locking configuration includes removing the constraining force.

In an application, removing the constraining force includes removing,from the lumen of at least one of the tubular elements, a rod that is(1) disposed in the lumen of the least one of the tubular elements, and(2) configured to provide the constraining force.

In an application, removing the constraining force includes removing,from around at least one of the tubular elements, a constraining sheaththat is (1) disposed around the at least one of the tubular elements,and (2) configured to provide the constraining force.

In an application, moving the apparatus into the locking configurationincludes rotating the second tubular element.

In an application, the first tubular element is coupled to the secondtubular element via a coupling point, and rotating the second tubularelement includes deflecting the second tubular element around thecoupling point.

There is further provided, in accordance with an application of thepresent invention, a method for use with one or more sutures at ananatomical site of a patient, the method including:

delivering, to a vicinity of the anatomical site, apparatus thatincludes (1) a casing, shaped to define a cavity, and one or moreopenings in which the sutures are disposable, and (2) a core, disposedin the cavity, and shaped to define a lumen in which the sutures aredisposable;

sliding the apparatus over at least part of the sutures while theapparatus is in an unlocked configuration thereof, in which the suturesare slidable through the openings and the lumen; and

subsequently, by moving the apparatus into a locking configurationthereof, simultaneously (1) inhibiting the sutures from sliding throughthe lumen by coupling the apparatus to the sutures at a coupling site ofthe apparatus, and (2) cutting the sutures with one or more cuttingedges at a cutting site of the apparatus.

In an application, the apparatus is configured to be constrained in theunlocked configuration by a constraining force, and moving the apparatusinto the locking configuration includes removing the constraining force.

In an application, removing the constraining force includes removing,from around at least part of the core, a constraining sheath that is (1)disposed around the at least part of the core, and (2) configured toprovide the constraining force.

For some applications, techniques described herein are practiced incombination with techniques described in one or more of the referencescited in the Background section and Cross-references section of thepresent patent application.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-B and 2A-B are schematic illustrations of apparatus comprisinga suture-securing device, in accordance with some applications of theinvention;

FIGS. 3-7 are schematic illustrations of stops in the use of theapparatus of FIGS. 1A-B and 2A-B to repair a cardiac valve, inaccordance with some applications of the invention;

FIGS. 8A-B and 9A-B are schematic illustrations of a suture-securingdevice, in accordance with some applications of the invention;

FIG. 10 is a schematic illustration of the suture-securing device ofFIGS. 8A-B and 9A-B, having been used to repair a cardiac valve, inaccordance with some applications of the invention;

FIGS. 11A-B are schematic illustrations of apparatus for repairing aheart valve, in accordance with some applications of the invention;

FIGS. 12A-F, 13A-B and 14 are schematic illustrations of the use or theapparatus of FIGS. 11A-B to repair a heart valve, in accordance withsome applications of the invention; and

FIG. 15 is a schematic illustration of the apparatus of FIGS. 11A-Bhaving been used to repair a heart valve, in accordance with someapplications of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is made to FIGS. 1A-B and 2A-B, which are schematicillustrations of apparatus 20, comprising a suture-securing device 22,in accordance with some applications of the invention. Device 22 has anunlocked configuration in which one or more sutures are generallyslidable through the device, and a locking configuration in which thesutures are generally not slidable through the device, and is movablefrom the unlocked configuration to the locking configuration.

FIGS. 1A-B show device 22 in the unlocked configuration thereof. FIG. 1Ashows a side view of device 22 being used with two sutures 34 a and 34b, and FIG. 1B shows a cutaway view of the same. It is to be noted that,although device 22 is shown being used with two individual sutures, thedevice may be used with two portions of the same suture (e.g., thesuture is looped), and/or with more or fewer sutures (e.g., to securethe device and/or an element coupled thereto, to a particular point on asingle suture). It is to be further noted that, although sutures 34 aand 34 b are shown as ribbon-like sutures (e.g., having a generallyrectangular cross-section), any suitable type of suture, as is known inthe art, may be used.

Device 22 comprises a first tubular element 24, which is shaped todefine a first lumen L1, a first end 10 and a second end 11, and asecond tubular element 26, which is shaped to define a second lumen, afirst end 12 and a second end 13. Typically, second tubular element 26is narrower than first tubular element 24. That is, lumen L2 typicallyhas a smaller transverse cross-sectional area than does lumen L1.Typically, the second tubular element has an outer edge that has adiameter D2 that is smaller than a diameter D1 of an inner edge of thefirst tubular element.

For some applications of the invention, diameter D1 is more than 1.1times greater and/or less than 1.5 times greater than diameter D2.Typically, second tubular element 26 has a longitudinal length (i.e.,from first end 12 to second end 13) that is smaller than diameter D1 offirst tubular element 24, e.g., so as to facilitate rotation of thesecond tubular element within lumen L1 of the first tubular element.

Typically, device 22 is used in catheter-based procedures orminimally-invasive procedures, and is positioned with respect to theoperating physician such that second tubular element 26 is distal tofirst tubular element 24. Alternatively, the device is positioned withrespect to the physician such that the first tubular element is distalto the second tubular element. For some applications, device 22 may beused in a surgical procedure, e.g., an open-heart procedure.

In the unlocked configuration of device 22, the first and second tubularelements are typically disposed end to end. That is, in the unlockedconfiguration of device 22, one or more of the following are typicallytrue:

(1) first end 12 of the second tubular element is disposed closer tofirst end 10 of the first tubular element than is second end 13 of thesecond tubular element,

(2) second end 13 of the second tubular element is disposed distally(i.e., with respect to the operating physician) to first end 12 of thesecond tubular element, and

(3) at least a quarter (e.g., all) of second tubular element 26 isdisposed outside of lumen L1 of the first tubular element.

In the unlocked configuration, sutures 34 a and 34 b are slidablethrough device 22, i.e., through lumens L1 and L2 of tubular elements 24and 26. That is, in the unlocked configuration, the device is slidablycoupled to the sutures, i.e., is slidable over the sutures. Typically,device 22 is delivered to an anatomical site (e.g., in a vicinity of asite being treated) with sutures 34 a and 34 b pre-threaded through thedevice.

Typically, and as shown in FIGS. 1A-B, device 22 comprises at least onehelical element, e.g., a coil. For example, and as shown in FIGS. 1A-B,tubular elements 24 and 26 may be defined by at least one helix. Furthertypically, device 22 comprises a continuous piece of material. Forexample, device 22 may be fabricated from a single elongate piece ofmaterial, such as a wire, that has been shaped to define tubularelements 24 and 26 (e.g., by being shaped to define a first helix thatdefines tubular element 24, and a second helix that defines tubularelement 26). Typically, the material comprises a metal such as, but notlimited to, stainless steel, titanium, nickel titanium (Nitinol), nickelcobalt, and/or cobalt chrome. For some applications, the materialcomprises a polymer and/or a resin. Further typically, and as describedhereinbelow with reference to FIGS. 2A-B, the material comprises ashape-memory material.

Helical elements 24 and 26 are typically coupled by a connecting portion38, which facilitates movement of device 22 from the unlockedconfiguration to the locking configuration. For some applications inwhich tubular elements 24 and 26 are defined by helices and comprise asingle piece of material, connecting portion 38 also comprises thesingle piece of material. That is, for such applications, device 22,comprising connecting portion 38, comprises a single piece of material.

FIGS. 2A-B show device 22 in the locking configuration thereof, i.e.,after having moved into the locking configuration. FIG. 2A shows a sideview of device 22 being used with two sutures 34 a and 34 b, and FIG. 2Bshows a cutaway view of the same. In the locking configuration of device22, second tubular element 26 is oriented at about 180 degrees comparedto its position in the unlocked configuration of the device. That is,when device 22 moved from the unlocked to the locking configuration, thesecond tubular element rotates and/or is deflected around an axis thatis generally orthogonal to a longitudinal axis from first end 10 of thefirst tubular element to second end 13 of the second tubular element.Typically, and as shown in FIGS. 2A-B, second tubular element 26 isdeflected around connecting portion 38.

Typically, in the locking configuration of device 22, one or more of thefollowing are true:

(1) second end 13 of the second tubular element is disposed closer tofirst end 10 of the first tubular element than is first end 12 of thesecond tubular element,

(2) first end 12 of the second tubular element is disposed distally(i.e., with respect to the operating physician) to second end 13 of thesecond tubular element, and

(3) at least a quarter of second tubular element 26 is disposed insidelumen L1 of the first tubular element.

In the locking configuration, sutures 34 a and 34 b are generally notslidable through device 22, i.e., through lumens L1 and L2 of tubularelements 24 and 26. That is, in the locking configuration, the device isfixedly coupled to the sutures, i.e., is generally not slidable over thesutures. Typically, the device is fixedly coupled to the sutures bysandwiching at least part of the sutures between the two tubularelements, e.g., between the outer edge of second tubular element 26 andthe inner edge first tubular element 24, as shown at coupling zone 31 inFIG. 2B.

As described hereinabove, device 22 (i.e., the tubular elements andcoupling portion thereof) typically comprises a single piece of materialthat has been fabricated into at least one helix. Typically, device 22comprises a shape-memory material, which is configured to be biased(e.g., is shape-set) such that the device moves toward the lockingconfiguration thereof. For such applications, the device is retained inthe unlocked configuration by at least one constraint 28 (see FIGS.1A-B), which provides a constraining force. That is, the lockingconfiguration is an unconstrained locking configuration, and theunlocked configuration is a constrained unlocked configuration.

For some applications, and as shown in FIGS. 1A-B, the constraintcomprises a rod 30, and the constraining force is provided by the distalend of the rod being disposed in lumen L2 of second tubular element 26.So as to move device 22 into the locking configuration (e.g., so as tofixedly couple the device to the sutures), the surgeon removes theconstraining force, e.g., by removing the constraint, such as bywithdrawing rod 30 from at least lumen L2, such that the deviceautomatically moves to the locking configuration.

For applications of the invention in which device 22 is constrained inthe unlocked configuration by rod 30, rod 30 is typically shaped todefine a lumen, and the sutures are slidable through the device by beingslidable through the lumen of the rod.

For some applications, device 22 is constrained in the unlockedconfiguration by a constraining sheath (not shown) for delivery to anintracorporeal site. At, or in the vicinity of, the intracorporeal site,the device is exposed from the delivery sheath and automatically movesinto the locking configuration.

Reference is made to FIGS. 3-7, which are schematic illustrationsshowing the use of apparatus 20 to treat a condition (e.g.,regurgitation or leaflet prolapse) of a cardiac valve 4 of a heart 2 ofa patient, in accordance with some applications of the invention. FIGS.3-7 show valve 4, comprising a tricuspid valve 94, being treated via aninferior vena cava 3 of the patient (e.g., transfemorally). However, thescope of the invention includes the treatment of other heart valves andthe use of other access routes, mutatis mutandis. In brief (1) distalends of sutures 34 a and 34 b are coupled to two sites on annulus 5 ofvalve 4, (2) the sutures are placed under tension with respect to eachother so as to draw the sites on the annulus toward each other, (3)apparatus is used to secure the sutures in the under-tensionconfiguration, and (4) the sutures are cut and released, so as to leavethe sutures under tension and the valve in the drawn-togetherconfiguration.

FIG. 3 shows a catheter 46 having been advanced through the inferiorvena cava and into the right atrium 7 of the heart of the patient. Viacatheter 46, a first helical anchor 40 a, coupled to a distal end ofsuture 34 a is coupled to (i.e., screwed into) a first site 6 on annulus5. Typically, anchor 40 a is delivered via a first inner sheath 44 a.Subsequently, and as shown in FIG. 4, a second helical anchor 40 b,coupled to a distal end of suture 34 b is coupled to a second site 8 onannulus 5. Typically, second site 8 is at least 1 cm from first site 6,such as a quarter of the way around annulus 5 from the first site, suchas on the opposite side of the annulus to the first site.

For some applications in which cardiac valve 4 comprises tricuspid valve94, first site 6 is typically in a vicinity of an anterior-posteriorcommissure (APC) 88 (i.e., the commissure between anterior leaflet 82and posterior leaflet 84) of the valve, and second site 8 is in avicinity of the septal leaflet of the valve.

Typically, anchor 40 b is delivered via a second inner sheath 44 b.Alternatively, anchors 40 a and 40 b are delivered via the same innersheath.

FIG. 5 shows apparatus 20, comprising suture-securing device 22, havingbeen advanced through catheter 46. For some applications, and as shownin FIG. 5, device 22 is delivered via an outer sheath 48. Device 22 istypically delivered in the unlocked configuration thereof, and istypically constrained in the unlocked configuration by rod 30, asdescribed hereinabove. Rod 30 and device 22 are slid over at least partof sutures 34 a and 34 b. For example, the sutures and helical anchorsmay be delivered via the lumen of rod 30 (e.g., inner sheaths 44 a and44 b may be advanced through the lumen of rod 30).

FIG. 6 shows sutures 34 a and 34 b having been placed under tension atleast with respect to each other, e.g., by pulling respective proximalends of the sutures proximally and/or by pushing device 22 distally,such as by using a controller 50. The tension draws together anchors 40a and 40 b, and thereby draws together sites 6 and 8. Thereby, theannulus of valve 4 is reshaped, so as to treat valve prolapse. Thisreshaping is typically monitored in real-time (e.g., using ultrasoundtechniques) so that the operating physician may determine whenacceptable reshaping has been achieved.

Reference is now made to FIG. 7. Once the operating physician determinesthat acceptable reshaping has been achieved, device 22 is moved into thelocking configuration, e.g., by withdrawing rod 30 proximally.Typically, sutures 34 a and 34 b are subsequently released, e.g., bybeing cut at a proximal side of device 22. Rod 30 and the sheaths andcatheter are subsequently removed from the body of the patient.

Reference is made to FIGS. 8A-B and 9A-B, which are schematicillustrations of a suture-securing device 60, in accordance with someapplications of the invention. Device 60 has an unlocked configurationin which one or more sutures are generally slidable through the device,and a locking configuration in which the sutures are generally notslidable through the device, and is movable from the unlockedconfiguration to the locking configuration.

FIGS. 8A-B show device 60 in the unlocked configuration thereof. FIG. 8Ashows a perspective view of device 60 being used with two sutures 34 aand 34 b, and FIG. 8B shows a cutaway view of the same. FIG. 8A furthershows an exploded view of device 60. It is to be noted that, althoughdevice 60 is shown being used with two individual sutures, the devicemay be used with two portions of the same suture (e.g., the suture islooped), and/or with more or fewer sutures (e.g., to secure the deviceand/or an element coupled thereto, to a particular point on a singlesuture).

Device 60 comprises a casing 62, shaped to define a cavity 63 and one ormore openings 64, and a core 66, disposed in cavity 63, and shaped todefine a lumen L3 therethrough. Typically, casing 62 defines twoopenings 64. Typically, cavity 63 is open at a lateral side of thecasing. Core 66 is movable, at least in part, within cavity 63.Typically, a pin 70 is disposed through casing 62 and core 66, such thatcore 66 is movable within cavity 63 without decoupling from casing 62.For example, and as shown in FIGS. 8A-9B, core 66 may be shaped todefine a socket 74 that has a transverse cross-sectional shape that islarger than a transverse cross-sectional shape of pin 70. Pin 70 isfixedly coupled to casing 62 and movably-coupled, via socket 74, to core66. Due to the difference in size between the respective cross-sectionalshapes of pin 70 and socket 74, core 66 is movable within cavity 63without decoupling from casing 62.

In the unlocked configuration of device 60, lumen L3 is typicallyaligned between openings 64, i.e., the lumen is typically disposed on anaxis between the openings. Typically, thereby, in the unlockedconfiguration, lumen L3 is generally in fluid communication withopenings 64.

In the unlocked configuration, sutures 34 a and 34 b are slidablethrough device 60, i.e., through openings 64 and lumen L3. That is, inthe unlocked configuration, the device is slidably coupled to thesutures, i.e., is slidable over the sutures. Typically, device 60 isdelivered to an anatomical site (e.g., in a vicinity of a site beingtreated) with sutures 34 a and 34 b pre-threaded through the device.

Device 60 typically further comprises and/or defines one or more cuttingedges, such as cutting edges 80 a and 80 b, described further withreference to FIGS. 9A-B.

FIGS. 9A-B show device 60 in the locking configuration thereof, i.e.,after having moved into the locking configuration. FIG. 9A shows aperspective view of device 60 being used with two sutures 34 a and 34 b,and FIG. 9B shows a cutaway view of the same. In the lockingconfiguration of device 60, lumen L3 is typically not aligned betweenopenings 64, i.e., the lumen is typically not disposed on an axisbetween the openings. Typically, thereby, in the locking configuration,lumen L3 is generally not in fluid communication with openings 64.

In the locking configuration, sutures 34 a and 34 b are generally notslidable through device 60, i.e., through openings 64 and lumen L3. Thatis, in the locking configuration, the device is fixedly coupled to thesutures, i.e., is generally not slidable over the sutures. Typically,the device is fixedly coupled to the sutures by sandwiching at leastpart of the sutures between core 66 and casing 62, as shown at couplingzone 61 in FIG. 9B.

When device 60 moves into the locking configuration, the device cuts thesutures disposed therein, at a cutting zone 65. Typically, a firstcutting edge 80 a is defined by casing 62, a second cutting edge 80 b isdefined by core 66, and when sutures 34 a and 34 b are slid throughdevice 60, part of each suture is disposed between the two cuttingedges. When device 60 moves into the locking configuration, the twocutting edges move toward and, typically, past each other, therebycutting the sutures.

A portion of each suture typically remains within device 60 subsequentto the fixed-coupling of the device to the sutures. For example, and asshown in FIG. 9B, coupling zone 61 may be disposed close to one end ofdevice 60 (e.g., in a vicinity of one opening 64), and cutting zone 65may be disposed close to another end of the device (e.g., in a vicinityof the other opening 64).

Device 60 is typically configured to be biased such that the devicemoves toward the locking configuration thereof. Typically, device 60 isthus configured by comprising at least one spring 72, which moves core66 with respect to casing 62. For such applications, the device isretained in the unlocked configuration by at least one constraint, whichprovides a constraining force. That is, the locking configuration is anunconstrained locking configuration, and the unlocked configuration is aconstrained unlocked configuration.

For example, a portion of core 66 may protrude from a lateral surface ofcasing 62 when the device is in the locking configuration, and theconstraint may comprise a delivery sheath (not shown), which inhibitsthat portion of core 66 from protruding thus. So as to move device 60into the locking configuration (e.g., so as to fixedly couple the deviceto the sutures, and to cut the sutures), the operating physician removesthe constraining force, e.g., by removing the constraint, such as bywithdrawing the sheath, such that the device automatically moves to thelocking configuration.

Reference is made to FIG. 10, which is a schematic illustration showingdevice 60 having been used to treat prolapse in cardiac valve 4, inaccordance with some applications of the invention. Typically, device 60is used in combination with the techniques described with reference toFIGS. 3-7, mutatis mutandis. FIG. 10 shows sutures 34 a and 34 b havingbeen (1) coupled to annulus 5 at sites 6 and 8, using helical anchors 40a and 40 b, (2) fixedly coupled to apparatus 60 and, thereby to eachother, and (3) cut using apparatus 60.

Reference is made to FIGS. 11A-14, which are schematic illustrations ofa system 100 for repairing heart valve 4, and steps in the use of thesystem for repairing the heart valve, in accordance with someapplications of the invention. System 100 comprises a support 102 and aplurality of leaflet-piercing elements 106, configured to couple thesupport to the heart valve by piercing the leaflets of the heart valveand coupling to the support. Typically, leaflet-piercing elements 106are deliverable to the valve independently of support 102.

Typically, system 100 comprises a securing element 104, which compriseselements 106. Securing element 104 typically further comprises a core108 and a plurality of arms 110. A respective inner end of each arm 110is coupled to core 108, from which the arms extend radially. Elements106 are coupled to respective outer ends of each arm. Typically,securing element 104 is deliverable to the valve independently ofsupport 102.

Coupling of securing element 104 to support 102 is facilitated byleaflet-piercing elements 106. Typically, support 102 has an innerperimeter 114 that defines an opening 115, and coupling of securingelement 104 to support 102 is further facilitated by at least part ofcore 108 of element 104 being disposed within opening 115. Typically,core 108 is shaped to define a coupling portion 109, which secures thecore within the opening. For example, coupling portion 109 may comprise,or be shaped to define, a ridge 111 which inhibits the core from beingdecoupled from opening 115 (e.g., coupling portion 109 locks core 108 tosupport 102).

FIG. 11A shows support 102 and securing element 104 individually, andFIG. 11B shows the securing element coupled to the support.

Typically, support 102 comprises a braided wire mesh, which, whenunconstrained, has an expanded configuration, and can be compressed intoa compressed configuration. Typically, support 102 is compressed intothe compressed configuration for delivery to the heart valve, isconstrained in the compressed configuration by a catheter via which thesupport is delivered, and automatically expands upon being released froma distal end of the catheter at the heart valve. Typically, in thecompressed configuration, the support is generally cylindrical in shape.In the uncompressed configuration, support 102 defines aleaflet-engaging side 118 (typically a downstream side of the support)that is typically a flat side. In the uncompressed configuration,support 102 itself is typically flat. Further typically, in theuncompressed configuration, the support defines two adjacent layers andis generally circular (i.e., disc-shaped).

Typically, securing element 104 has a delivery configuration in whicharms 110 are disposed distally to core 108, and is configured to bemovable to a deployed configuration following delivery to the heartvalve. Typically, element 104 is configured to be constrained in thedelivery configuration by a delivery sheath, and to automatically movetoward the deployed configuration upon being exposed from the sheath atthe heart valve.

FIGS. 11A-14 show apparatus 100, and its use in treating tricuspid valve94 via inferior vena cava 3 of the patient. However, the scope of theinvention includes the treatment of other heart valves and the use ofother access routes, mutatis mutandis. Additionally, securing element104 is shown comprising 6 arms and leaflet-piercing elements, but maycomprise other pluralities of arms and leaflet-piercing elements.

FIGS. 12A-F show steps in the use of apparatus 100 to treat (e.g., torepair) valve 4, in accordance with some applications of the invention.A catheter 120 is advanced to the valve; typically to right atrium 7 viainferior pulmonary artery 3 (e.g., transfemorally), as shown in FIG.12A. FIG. 12B shows a delivery sheath 122 having been advanced out of adistal end of catheter 120 and, via valve 4, to a downstream side of thevalve (i.e., into right ventricle 9) of the patient. FIG. 12B furthershows securing element 104 having been moved (e.g., advanced distally)out of delivery sheath 122 and into ventricle 9, and expanding into thedeployed configuration.

Subsequently, securing element 104 is moved (e.g., pulled) proximally,such that leaflet-piercing elements 106 pierce the leaflets of thevalve, thereby coupling the securing element to the leaflets, as shownin FIG. 12C. Securing element 104 is shown comprising six arms andleaflet-piercing elements, and being coupled to the leaflets such thattwo leaflet-piercing elements pierce (i.e., couple to) each leaflet. Itis to be noted that the scope of the present invention includes securingelement 104 comprising other pluralities of arms and/or leaflet-piercingelements, and other configurations of coupling to the leaflets.

Subsequently, as shown in FIG. 12D-E, support 102 is delivered to anupstream side of the valve (i.e., into right atrium 7). Typically,support 102 is advanced through catheter 120 and, upon being exposedfrom the end of the catheter, automatically expands into its expandedconfiguration. Typically, delivery sheath 122 is typically disposedwithin opening 115 of the support. That is, perimeter 114 of the supportis disposed around delivery sheath 122, which is typically still coupledto securing element 104. For some applications, delivery sheath 122 iscoupled to securing element 104 by a lock 124 (see FIG. 13A), which iscontrollable from outside of the body of the patient. For some suchapplications, lock 124 is directly coupled to delivery sheath 122.Alternatively, lock 124 is coupled to a controller (e.g., a controlwire; not shown) that is disposed within sheath 122.

Support 102 is placed against the leaflets of the valve (e.g.,leaflet-engaging side 118 of the support is placed against the upstreamsurface of the leaflets), typically by being slid over delivery sheath122. That is, delivery sheath 122 typically acts as a guide for support102. FIG. 12E shows a perspective view, and FIG. 13A shows a respectivecutaway view, of support 102 disposed against the leaflets. Typically,support 102 is placed, and is configured to be placed, against theleaflets of the valve such that the support overlaps more than oneleaflet. That is, the support is typically placed such that respectiveportions of the leaflet-engaging side of the support are disposedagainst respective regions of respective leaflets of the valve.

FIGS. 12F and 13B show respective perspective and cutaway views ofsupport 102 having been fixedly coupled to securing element 104, therebysandwiching the leaflets of the valve between the support and thesecuring element. Leaflet-piercing elements 106 typically protrude into(e.g., through) support 102. FIGS. 12F and 13B also show catheter 120and sheath 122 having been removed from the body of the patient.Typically, this fixed coupling is performed by securing element 104 isheld immobile or pulled proximally, while support 102 is pusheddistally, such that inner perimeter 114 of the support is slid over atleast part of core 108 of the coupling element. For example, the supportmay be slid over coupling portion 109, such that ridge 111 is ‘clicked’into place. Typically, support 102 is pushed distally using catheter 120and/or a separate controller (not shown). If support 102 is pushed usingcatheter 120, the catheter has an outer diameter that is greater thanthe diameter of opening 115 of the support.

FIG. 13B shows arms 110 of securing element 104 as being bent comparedto the appearance of the arms in FIG. 13A. For some applications of theinvention, arms 110 are resilient, and are configured to be bent by thecoupling of element 104 to support 102, acting like a spring. Thisconfiguration facilitates the coupling of apparatus 100 to the valveleaflets by transferring force from the coupling of coupling portion 109and perimeter 114, to leaflet-piercing elements 106, thereby holdingleaflet-piercing elements 106 within the leaflets and within mesh 112 ofsupport 102. That is, coupling of coupling portion 109 of core 108 tothe support facilitates coupling of the leaflet-piercing elements to thesupport. For some applications of the invention, leaflet-piercingelements 106 comprise straight spikes. For other applications of theinvention, leaflet-piercing elements 106 comprise barbs or hooks, so asto facilitate fixed coupling of the leaflet-piercing elements directlyto mesh 112.

As shown in FIGS. 12F and 13B, when apparatus 100 is implanted (i.e.,coupled to the leaflets of the heart valve), arms 110 of securingelement 104 are typically disposed on one side of the valve, and bothcoupling portion 109 and leaflet-piercing elements 106 are coupled tosupport 102 on the other side of the valve. Thereby, for someapplications, securing element 104 is coupled to support 102 only at theupstream side of the heart valve of the patient.

FIGS. 12A-13B show securing element 104 being moved proximally (i.e.,upstream), so as to couple to the valve leaflets, prior to the deliveryof support 102. However, for some applications of the invention, support102 is delivered before moving element 104 proximally.

FIG. 14 is an atrial-side view of apparatus 100 having been used torepair valve 4 (e.g., tricuspid valve 94), as described in FIGS.12A-13B. Support 102 is typically coupled to the leaflets of the valvesuch that the support overlaps more than one leaflet. That is, thesupport is typically coupled to the valve such that respective regionsof the support are disposed against respective portions of respectiveleaflets of the valve. The cusps of the leaflets of the valve aretypically held close to each other (e.g., touching each other) byapparatus 100, which is thereby disposed generally centrally in thevalve. Typically, portions of the leaflets between apparatus 100 and theleaflet commissures (e.g., APC 88) are not held close to each other, andmove with the beating of the heart. That is, these portions of theleaflets typically open during ventricular diastole and close duringventricular systole, thereby forming three orifices which typically actas separate valves. FIG. 14 shows these portions of the leaflets open(i.e., during diastole), such that right ventricle 9 is visibletherebetween.

For some applications of the invention, support 102 is dimensioned tocover more than 10% and/or less than 90% (e.g., between 10% and 90%,such as between 10% and 30%) of the area defined by the native orificeof the heart valve. For example, a support of desired dimensions may beselected according to the valve and/or patient being treated (e.g.,following measurement of the valve being treated).

It is hypothesized that the use of apparatus 100 as described withreference to FIGS. 11-14 reduces heart valve regurgitation, and may beused to repair a diseased heart valve.

Reference is now made to FIG. 15. Although apparatus 100 is shownhereinabove being configured and used, to repair tricuspid valve 94, theapparatus may be configured and used with other heart valves. Forexample, FIG. 15 shows apparatus 100 having been used to repair a mitralvalve 130 of a patient, whereby support 102 is disposed in a rightatrium 137 of the patient, and securing element 104 (not visible in FIG.15) is disposed in a right ventricle 139 of the patient. For a bicuspidheart valve such as mitral valve 130, two orifices are typically formedbetween apparatus 100 and the commissures.

Apparatus 100 is typically coupled to the heart valve being treated,such that support 102 is disposed against an upstream side of the valve(i.e., an upstream side of the valve leaflets), and securing element 104is disposed against a downstream side of the valve (i.e., against adownstream side of the valve leaflets). However, for some applications,apparatus 100 is coupled to the heart valve such that support 102 isdisposed against the downstream side of the valve, and securing element104 is disposed against the upstream side of the valve.

Apparatus 100 is typically delivered to the heart valve percutaneously(e.g., transcatheterally and/or transluminally). Apparatus 100 is shownbeing delivered transluminally from an upstream side of the valve (e.g.,via the inferior vena cava). That is, typically, from the perspective ofthe operating physician, the upstream side of the valve is the proximalside of the valve, and the downstream side of the valve is the distalside of the valve. However, it is to be noted that the scope of thepresent invention includes delivery from a downstream side of the valve(e.g., transapically, or via the aorta), mutatis mutandis.

Reference is now made to FIGS. 8A-15. Typically, device 60 (FIGS. 8A-10)and system 100 (9A-15) are used in catheter-based procedures orminimally-invasive procedures. For some applications, device 60 (FIGS.8A-10) and system 100 (9A-15) may be used in a surgical procedure, e.g.,an open-heart procedure.

Reference is made to FIGS. 1A-15. It is to be noted that devices 22 and60, and system 100 described herein may be used in any suitable locationin the body of the patient. For example, devices 22 and 60 can be usedto secure sutures in any part of the body. Additionally, it is to benoted that devices 22 and 60, and system 100 described herein may beused in any cardiac valve (i.e., the mitral, the tricuspid, thepulmonary, and the aortic valve) of the patient.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

1-95. (canceled)
 96. A suture-securing device for use with one or moresutures, the suture-securing device comprising: a first tubular element,shaped to define a first lumen therethrough, and having a first end anda second end; and a second tubular element, shaped to define a secondlumen therethrough, and having a first end and a second end, wherein thesuture-securing device is configured to have: (a) an unlockedconfiguration in which: the first end of the second tubular element isdisposed closer to the first end of first tubular element than is thesecond end of the second tubular element, and the sutures are disposablewithin and slidable through the first and second lumens, and (b) alocking configuration in which: the second end of the second tubularelement is disposed closer to the first end of first tubular elementthan is the first end of the second tubular element, and the sutures areinhibited from sliding through the first and second lumens.
 97. Thesuture-securing device according to claim 96, wherein the second tubularelement has a length, from the first end of the second tubular elementto the second end of the second tubular element, that is smaller than across-sectional diameter of the first lumen.
 98. The suture-securingdevice according to claim 96, wherein the suture-securing device isconfigured such that: in the unlocked configuration, the second end ofthe second tubular element is disposed outside of the first lumen, andin the locking configuration, the second end of the second tubularelement is disposed within the first lumen.
 99. The suture-securingdevice according to claim 96, wherein the second end of first tubularelement is coupled to the first end of the second tubular element. 100.The suture-securing device according to claim 96, wherein thesuture-securing device is configured such that, when the sutures aredisposed within the lumens of the first and second tubular elements,movement of the suture-securing device from the unlocked to the lockingconfiguration rotates at least a portion of each suture.
 101. Thesuture-securing device according to claim 96, wherein thesuture-securing device is configured such that movement of thesuture-securing device from the unlocked to the locking configurationrotates the second tubular element.
 102. The suture-securing deviceaccording to claim 96, wherein the unlocked configuration is aconstrained configuration, and the locking configuration is anunconstrained configuration, and wherein the suture-securing device isconfigured to be retained in the constrained unlocked configuration by aconstraining force, and to automatically move toward the unconstrainedlocking configuration when the constraining force is removed.
 103. Asystem comprising the suture-securing device according to claim 102,wherein the system further comprises a constraint, configured to providethe constraining force.
 104. The system according to claim 103, whereinthe constraint comprises a rod, disposable in the lumen of at least oneof the tubular elements, configured to provide the constraining force bybeing disposed in the lumen, the constraining force being removable byremoving the rod from the lumen.
 105. The suture-securing deviceaccording to claim 96, wherein the first and second tubular elementsboth define respective inner and outer surfaces, and wherein, in thelocking configuration, at least part of the outer surface of the secondtubular element is disposed against at least part of the inner surfaceof first tubular element.
 106. The suture-securing device according toclaim 105, wherein the suture-securing device is configured such that,when the sutures are disposed within the lumens of the first and secondtubular elements, movement of the suture-securing device from theunlocked to the locking configuration sandwiches at least a portion ofeach suture between the outer surface of the second tubular element andthe inner surface of first tubular element.
 107. The suture-securingdevice according to claim 96, wherein the suture-securing devicecomprises at least one helical element.
 108. The suture-securing deviceaccording to claim 107, wherein, at least in the unlocked configuration,the suture-securing device defines a continuous helix from the first endof first tubular element to the second end of the second tubularelement.
 109. The suture-securing device according to claim 96, whereinthe second end of first tubular element is coupled to the first end ofthe second tubular element by a connecting portion.
 110. Thesuture-securing device according to claim 109, wherein the tubularelements and the connecting portion comprise a continuous piece ofmaterial.
 111. The suture-securing device according to claim 96, whereinthe suture-securing device is configured such that: in the unlockedconfiguration, at least a quarter of the second tubular element isdisposed outside of the first lumen, and in the locking configuration,at least a quarter of the second tubular element is disposed inside thefirst lumen.
 112. The suture-securing device according to claim 96,wherein the second tubular element is coupled to first tubular elementat a coupling point, the coupling point being configured to facilitatedeflection of the second tubular element around the coupling point,wherein the suture-securing device is configured: to be constrainable inthe unlocked configuration by a constraining force, and when theconstraining force is removed, to automatically move from the unlockedconfiguration to the locking configuration, by the second tubularelement deflecting around the coupling point.
 113. The suture-securingdevice according to claim 112, wherein the first and second tubularelements both define respective inner and outer surfaces, and wherein,in the locking configuration, at least part of the outer surface of thesecond tubular element is disposed against at least part of the innersurface of first tubular element.
 114. The suture-securing deviceaccording to claim 113, wherein the suture-securing device is configuredsuch that, when the sutures are disposed within the lumens of the firstand second tubular elements, the deflecting of the second tubularelement around the coupling point sandwiches at least a portion of eachsuture between the outer surface of the second tubular element and theinner surface of first tubular element.
 115. A method for use with oneor more sutures at an anatomical site of a patient, the methodcomprising: delivering, to a vicinity of the anatomical site, asuture-securing device that includes (1) a first tubular element, shapedto define a first lumen therethrough, and having a first end and asecond end, and (2) a second tubular element, shaped to define a secondlumen therethrough, and having a first end and a second end; sliding thesuture-securing device over at least part of the sutures while thesuture-securing device is in an unlocked configuration thereof in which(1) the first end of the second tubular element is disposed closer tothe first end of first tubular element than is the second end of thesecond tubular element, and (2) the sutures are slidable through thefirst and second lumens; and securing the suture-securing device to thesutures by moving the suture-securing device into a lockingconfiguration thereof in which: (1) the second end of the second tubularelement is disposed closer to the first end of first tubular elementthan is the first end of the second tubular element, and (2) the suturesare inhibited from sliding through the first and second lumens.